HypertensionPhase 1NCT03099226
Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Dose Regimens of BIA 5-453
A Phase 1 study testing BIA 5-453 in people with Hypertension, run by Bial - Portela C S.A. at 1 site in France.
Trial summary
The purpose of this study was to characterise the plasma and urine pharmacokinetic profile of Etamicastat (BIA 5-453) and its metabolites after three multiple rising dose regimens of Etamicastat (BIA 5-453). Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Hypertension
- What is being tested?
- BIA 5-453
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jul 2008to 3 Apr 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A signed and dated informed consent form before any study-specific screening procedure is performed.
- Male patients aged between 18 and 65 years (inclusive)
- Body mass index (BMI) between 18 and 35 kg/m2 (inclusive)
- Patients with essential hypertension, without previous treatment (but in which treatment was justified), defined at the selection visit as blood pressure (BP) after 10 minutes of rest in supine position of
- diastolic blood pressure (DBP) ≥ 90 mmHg and/or,
- systolic blood pressure (SBP) ≥ 140 mmHg
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- Patients with essential hypertension, with previous treatment, defined at the end of the screening period (i.e. after 3 weeks wash-out of antihypertensive treatment(s) and before D-1) as blood pressure (BP) after 10 minutes of rest in supine position of
- diastolic blood pressure (DBP) ≥ 90 mmHg and/or,
- systolic blood pressure (SBP) ≥ 140 mmHg
- Naive or patients taking any class of antihypertensive treatment including (but not limited to) one of the following authorised treatments: B-blockers, diuretics, angiotensin-converting enzyme inhibitor (ACEI), angiotensin receptor blocker (ARB), calcium channel blockers. Patients observed a wash-out for their antihypertensive treatments of approximately 3 weeks.
- Laboratory tests within the normal range of the laboratory (haematology, biochemistry and urinalysis) or considered as not clinically significant by the investigator.
- Electrocardiogram recording on a 12-lead ECG without any clinically significant abnormality
- Covered by National Health Insurance
- Once clinical eligibility had been established, patients conducted 24 h ambulatory blood pressure monitoring (ABPM) at the end of the screening period, and after treatment wash-out for patients already treated. They had to meet the following off-treatment criteria for mean 24 h ambulatory blood pressure measurements to be included in the study:
- Average daytime ambulatory systolic/diastolic BP ≥ 135 / 85 mm Hg and/or
- Ambulatory night-time systolic/diastolic BP ≥ 120 / 70 mm Hg.
Who cannot join
- Criteria associated with hypertension, associated risk factors, and target organ damage:
- Severe hypertension (SBP≥180 mm Hg and/or DBP≥110 mm Hg) at any time during the study from screening period to end of study visit or in the medical history, malignant hypertension
- Secondary hypertension (including known renovascular hypertension, pheochromocytoma)
- Any recent history of coronary artery disease (in the previous 6 months) and including myocardial infarction, or precordial pain suggesting angina pectoris and coronary revascularisation
- Any recent history of cardiac failure (in the previous 6 months)
- Any recent history of cerebrovascular stroke or transient ischemia (in the previous 6 months)
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- Any known aortic or mitral valve stenosis or hypertrophic obstructive myocardiopathy
- Any known severe ocular complication of hypertension (stage III or IV retinopathy),
- Any history of ventricular rhythm disorders (torsades de pointes, ventricular tachycardia, polymorphic ventricular extra-systoles except isolated extra-systoles), auricular disorders (fibrillation or flutter).
- Any surgical or medical condition that might significantly alter the absorption, distribution, metabolism, or excretion of Etamicastat (BIA 5-453)
- Presence or history of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, haematological, neurological or psychiatric disease.
- Frequent headaches and/or migraine, recurrent nausea and/or vomiting (more than twice a month).
- Criteria associated with patient characteristic:
- History or presence of drug dependence.
- Patients smoking more than 10 cigarettes per day
- History of alcoholism within 1 year before day 1. Consumption of more than 50 g of ethanol per day (12.5 cL glass of 10° [10%] wine = 12 g; 4 cL of aperitif, 42° [42%] whiskey = 17 g; 25 cL glass of 3° [3%] beer = 7.5 g; 25 cL glass of 6° [6%] beer = 15 g
- Participation in a drug trial within 3 months preceding the selection visit.
- Positive result from the hepatitis serology for hepatitis B (HBs Ag) and/or hepatitis C (HCV Ab).
- Positive result for HIV1+2 serology.
- Positive Urine Drug Screen (UDS) (amphetamines, benzodiazepines, ecstasy, cocaine, opiates).
- Loss of greater than 400 mL or blood donation within the last 3 months.
- Criteria associated with concomitant diseases:
- Patients taking one of the following treatments: aldosterone antagonists, nitrite derivatives.
- Presence or history of any allergic or unusual reaction to drugs.
- Excessive consumption of beverages containing xanthine bases (more than six cups or glasses per day) or inability to stop consumption during the hospitalization.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Randomised, Placebo-controlled Study to Evaluate the Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Dose Regimens of Etamicastat (BIA 5-453) in Hypertensive Subjects
The purpose of this study was to characterise the plasma and urine pharmacokinetic profile of Etamicastat (BIA 5-453) and its metabolites after three multiple rising dose regimens of Etamicastat (BIA 5-453).
Read the detailed description
Single centre, double-blind, randomised, placebo-controlled study of three dosage regimens of Etamicastat (BIA 5-453) in 3 groups of 8 hypertensive patients.
In each group, the study consisted of a 10-day multiple-dose period. Progression to the next dose level only occurred if the previous dose level was considered to be safe and well tolerated. An appropriate interval separated the investigation of doses to permit a timely review and evaluation of safety data prior to proceeding to a higher dose level.
- Conditions
- Hypertension
- Being tested
- Placebo, BIA 5-453
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo blue hard gelatine capsules
BIA 5-453Drug
Also called Etamicastat
Etamicastat (BIA 5-453) blue hard gelatine capsules - 50 Strength (mg)
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - BIA 5-453 50 mg or placebo | Experimental | This study investigated the doses of 50, 100 and 200 mg of Etamicastat (BIA 5-453) during 10 days administered q.d. in the morning under fasting conditions.
On Day 1 and Day 10, patients remained fasted from a minimum of 8 hours before drug administration until after the collection of the 4 hour PK timepoint. Individuals were served a meal following the 4 hour timepoint and had free access to a maximum of 2.5 litres of water per day. However they were not allowed to drink 1 hour before and 1 hour after the dosing except for the 250 mL taken with the IMP at administration.
On other administrations days, patients remained fasted for a minimum of 8 hours before drug administration and the treatments were administered one hour before a standardized breakfast.
The patients were administered between 7:00 and 9:00 o'clock a.m Receives: Drug: Placebo; Drug: BIA 5-453 |
| Group 2 - BIA 5-453 100 mg or placebo | Experimental | This study investigated the doses of 50, 100 and 200 mg of Etamicastat (BIA 5-453) during 10 days administered q.d. in the morning under fasting conditions.
On Day 1 and Day 10, patients remained fasted from a minimum of 8 hours before drug administration until after the collection of the 4 hour PK timepoint. Individuals were served a meal following the 4 hour timepoint and had free access to a maximum of 2.5 litres of water per day. However they were not allowed to drink 1 hour before and 1 hour after the dosing except for the 250 mL taken with the IMP at administration.
On other administrations days, patients remained fasted for a minimum of 8 hours before drug administration and the treatments were administered one hour before a standardized breakfast.
The patients were administered between 7:00 and 9:00 o'clock a.m Receives: Drug: Placebo; Drug: BIA 5-453 |
| Group 3 - BIA 5-453 200 mg or placebo | Experimental | This study investigated the doses of 50, 100 and 200 mg of Etamicastat (BIA 5-453) during 10 days administered q.d. in the morning under fasting conditions.
On Day 1 and Day 10, patients remained fasted from a minimum of 8 hours before drug administration until after the collection of the 4 hour PK timepoint. Individuals were served a meal following the 4 hour timepoint and had free access to a maximum of 2.5 litres of water per day. However they were not allowed to drink 1 hour before and 1 hour after the dosing except for the 250 mL taken with the IMP at administration.
On other administrations days, patients remained fasted for a minimum of 8 hours before drug administration and the treatments were administered one hour before a standardized breakfast.
The patients were administered between 7:00 and 9:00 o'clock a.m Receives: Drug: BIA 5-453 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax: Maximum observed plasma concentration (Plasma results on Day 1)
Plasma pharmacokinetic parameters (SD) following single and repeated doses of 50, 100, and 200 mg of Etamicastat (BIA 5-453) in hypertensive subjects
Measured: D1 pre-dose, and H0.5 , 1, 2, 3, 4, 5, 6, 8, 10, 12, 16 post-dose
tmax: time to reach maximum plasma concentration (Plasma results on Day 1)
Plasma pharmacokinetic parameters (SD) following single and repeated doses of 50, 100, and 200 mg of Etamicastat (BIA 5-453) in hypertensive subjects
Measured: D1 pre-dose, and H0.5 , 1, 2, 3, 4, 5, 6, 8, 10, 12, 16 post-dose
AUC0-t: Area under the plasma concentration-time curve from time zero to last measurable plasma concentration (Plasma results on Day 1)
Plasma pharmacokinetic parameters (SD) following single and repeated doses of 50, 100, and 200 mg of Etamicastat (BIA 5-453) in hypertensive subjects
Measured: D1 pre-dose, and H0.5 , 1, 2, 3, 4, 5, 6, 8, 10, 12, 16 post-dose
AUC0-24: AUC from time zero to 24h-post dose (Plasma results on Day 1)
Plasma pharmacokinetic parameters (SD) following single and repeated doses of 50, 100, and 200 mg of Etamicastat (BIA 5-453) in hypertensive subjects
Measured: D1 pre-dose, and H0.5 , 1, 2, 3, 4, 5, 6, 8, 10, 12, 16 post-dose
Cmax: Maximum observed plasma concentration (Plasma results on Day 10)
Plasma pharmacokinetic parameters (SD) following single and repeated doses of 50, 100, and 200 mg of Etamicastat (BIA 5-453) in hypertensive subjects
Measured: D10 pre-dose, and H0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12,16, 24, 48 and 72 h post-dose
tmax: time to reach maximum plasma concentration (Plasma results on Day 10)
Plasma pharmacokinetic parameters (SD) following single and repeated doses of 50, 100, and 200 mg of Etamicastat (BIA 5-453) in hypertensive subjects
Measured: D10 pre-dose, and H0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12,16, 24, 48 and 72 h post-dose
AUC0-t: Area under the plasma concentration-time curve from time zero to last measurable plasma concentration (Plasma results on Day 10)
Plasma pharmacokinetic parameters (SD) following single and repeated doses of 50, 100, and 200 mg of Etamicastat (BIA 5-453) in hypertensive subjects
Measured: D10 pre-dose, and H0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12,16, 24, 48 and 72 h post-dose
AUC0-24: AUC from time zero to 24h-post dose (Plasma results on Day 10)
Plasma pharmacokinetic parameters (SD) following single and repeated doses of 50, 100, and 200 mg of Etamicastat (BIA 5-453) in hypertensive subjects
Measured: D10 pre-dose, and H0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12,16, 24, 48 and 72 h post-dose
C max : Maximum excretion rate (Urine results on Day 1)
Urine pharmacokinetic parameters (SD) following single and repeated doses of 100 and 200 mg of Etamicastat (BIA 5-453) in hypertensive subjects
Measured: D1 pre-dose, and 0-4, 4-8, 8-12, 12-24 h post-dose
tmax : Time of Maximum Excretion Rate (Urine results on Day 1)
Urine pharmacokinetic parameters (SD) following single and repeated doses of 100 and 200 mg of Etamicastat (BIA 5-453) in hypertensive subjects
Measured: D1 pre-dose, and 0-4, 4-8, 8-12, 12-24 h post-dose
AURC(0-tlast) : Area Under the Urine Excretion Curve from time zero to last time (Urine results on Day 1)
Urine pharmacokinetic parameters (SD) following single and repeated doses of 100 and 200 mg of Etamicastat (BIA 5-453) in hypertensive subjects
Measured: D1 pre-dose, and 0-4, 4-8, 8-12, 12-24 h post-dose
AmtCUM : Cumulative Amount of Drug excreted in urine (Urine results on Day 1)
Urine pharmacokinetic parameters (SD) following single and repeated doses of 100 and 200 mg of Etamicastat (BIA 5-453) in hypertensive subjects
Measured: D1 pre-dose, and 0-4, 4-8, 8-12, 12-24 h post-dose
C max : Maximum excretion rate (Urine results on Day 10)
Urine pharmacokinetic parameters (SD) following single and repeated doses of 100 and 200 mg of Etamicastat (BIA 5-453) in hypertensive subjects
Measured: D10 pre-dose, and 0-4, 4-8, 8-12, 12-24, 24-48, 48 72 h post-dose
tmax : Time of Maximum Excretion Rate (Urine results on Day 10)
Urine pharmacokinetic parameters (SD) following single and repeated doses of 100 and 200 mg of Etamicastat (BIA 5-453) in hypertensive subjects
Measured: D10 pre-dose, and 0-4, 4-8, 8-12, 12-24, 24-48, 48 72 h post-dose
AURC(0-tlast) : Area Under the Urine Excretion Curve from time zero to last time (Urine results on Day 10)
Urine pharmacokinetic parameters (SD) following single and repeated doses of 100 and 200 mg of Etamicastat (BIA 5-453) in hypertensive subjects
Measured: D10 pre-dose, and 0-4, 4-8, 8-12, 12-24, 24-48, 48 72 h post-dose
AmtCUM : Cumulative Amount of Drug excreted in urine (Urine results on Day 10)
Urine pharmacokinetic parameters (SD) following single and repeated doses of 100 and 200 mg of Etamicastat (BIA 5-453) in hypertensive subjects
Measured: D10 pre-dose, and 0-4, 4-8, 8-12, 12-24, 24-48, 48 72 h post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start15 Jul 2008
- Primary completion3 Apr 2009
- Study completion3 Apr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bial - Portela C S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03099226
- Sponsor's protocol ID
- BIA-5453-201HT
- Status last verified
- Mar 2017
- First submitted
- 28 Mar 2017
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomised, Placebo-controlled Study to Evaluate the Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Dose Regimens of Etamicastat (BIA 5-453) in Hypertensive Subjects
- ClinicalTrials.gov ID
- NCT03099226
- Acronym / sponsor ID
- BIA-5453-201HT
- Conditions
- Hypertension
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Bial - Portela C S.A.Industry (pharma, biotech, devices)
- Study start
- 15 Jul 2008 (actual)
- Primary completion
- 3 Apr 2009 (actual)
- Study completion
- 3 Apr 2009 (actual)
- First posted
- 4 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to characterise the plasma and urine pharmacokinetic profile of Etamicastat (BIA 5-453) and its metabolites after three multiple rising dose regimens of Etamicastat (BIA 5-453).
Detailed description
Single centre, double-blind, randomised, placebo-controlled study of three dosage regimens of Etamicastat (BIA 5-453) in 3 groups of 8 hypertensive patients.
In each group, the study consisted of a 10-day multiple-dose period. Progression to the next dose level only occurred if the previous dose level was considered to be safe and well tolerated. An appropriate interval separated the investigation of doses to permit a timely review and evaluation of safety data prior to proceeding to a higher dose level.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 - BIA 5-453 50 mg or placebo | Experimental | Drug: Placebo, Drug: BIA 5-453This study investigated the doses of 50, 100 and 200 mg of Etamicastat (BIA 5-453) during 10 days administered q.d. in the morning under fasting conditions. On Day 1 and Day 10, patients remained fasted from a minimum of 8 hours before drug administration until after the collection of the 4 hour PK timepoint. Individuals were served a meal following the 4 hour timepoint and had free access to a maximum of 2.5 litres of water per day. However they were not allowed to drink 1 hour before and 1 hour after the dosing except for the 250 mL taken with the IMP at administration. On other administrations days, patients remained fasted for a minimum of 8 hours before drug administration and the treatments were administered one hour before a standardized breakfast. The patients were administered between 7:00 and 9:00 o'clock a.m |
| Group 2 - BIA 5-453 100 mg or placebo | Experimental | Drug: Placebo, Drug: BIA 5-453This study investigated the doses of 50, 100 and 200 mg of Etamicastat (BIA 5-453) during 10 days administered q.d. in the morning under fasting conditions. On Day 1 and Day 10, patients remained fasted from a minimum of 8 hours before drug administration until after the collection of the 4 hour PK timepoint. Individuals were served a meal following the 4 hour timepoint and had free access to a maximum of 2.5 litres of water per day. However they were not allowed to drink 1 hour before and 1 hour after the dosing except for the 250 mL taken with the IMP at administration. On other administrations days, patients remained fasted for a minimum of 8 hours before drug administration and the treatments were administered one hour before a standardized breakfast. The patients were administered between 7:00 and 9:00 o'clock a.m |
| Group 3 - BIA 5-453 200 mg or placebo | Experimental | Drug: BIA 5-453This study investigated the doses of 50, 100 and 200 mg of Etamicastat (BIA 5-453) during 10 days administered q.d. in the morning under fasting conditions. On Day 1 and Day 10, patients remained fasted from a minimum of 8 hours before drug administration until after the collection of the 4 hour PK timepoint. Individuals were served a meal following the 4 hour timepoint and had free access to a maximum of 2.5 litres of water per day. However they were not allowed to drink 1 hour before and 1 hour after the dosing except for the 250 mL taken with the IMP at administration. On other administrations days, patients remained fasted for a minimum of 8 hours before drug administration and the treatments were administered one hour before a standardized breakfast. The patients were administered between 7:00 and 9:00 o'clock a.m |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- A signed and dated informed consent form before any study-specific screening procedure is performed.
- Male patients aged between 18 and 65 years (inclusive)
- Body mass index (BMI) between 18 and 35 kg/m2 (inclusive)
- Patients with essential hypertension, without previous treatment (but in which treatment was justified), defined at the selection visit as blood pressure (BP) after 10 minutes of rest in supine position of
- Patients with essential hypertension, with previous treatment, defined at the end of the screening period (i.e. after 3 weeks wash-out of antihypertensive treatment(s) and before D-1) as blood pressure (BP) after 10 minutes of rest in supine position of
Key exclusion criteria (25 listed)
- Severe hypertension (SBP≥180 mm Hg and/or DBP≥110 mm Hg) at any time during the study from screening period to end of study visit or in the medical history, malignant hypertension
- Secondary hypertension (including known renovascular hypertension, pheochromocytoma)
- Any recent history of coronary artery disease (in the previous 6 months) and including myocardial infarction, or precordial pain suggesting angina pectoris and coronary revascularisation
- Any recent history of cardiac failure (in the previous 6 months)
- Any recent history of cerebrovascular stroke or transient ischemia (in the previous 6 months)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo blue hard gelatine capsules | Drug | Group 1 - BIA 5-453 50 mg or placebo, Group 2 - BIA 5-453 100 mg or placebo |
| BIA 5-453Also: EtamicastatEtamicastat (BIA 5-453) blue hard gelatine capsules - 50 Strength (mg) | Drug | Group 1 - BIA 5-453 50 mg or placebo, Group 2 - BIA 5-453 100 mg or placebo, Group 3 - BIA 5-453 200 mg or placebo |
Primary outcome
Cmax: Maximum observed plasma concentration (Plasma results on Day 1)
Time frame: D1 pre-dose, and H0.5 , 1, 2, 3, 4, 5, 6, 8, 10, 12, 16 post-dose
Plasma pharmacokinetic parameters (SD) following single and repeated doses of 50, 100, and 200 mg of Etamicastat (BIA 5-453) in hypertensive subjects
tmax: time to reach maximum plasma concentration (Plasma results on Day 1)
Time frame: D1 pre-dose, and H0.5 , 1, 2, 3, 4, 5, 6, 8, 10, 12, 16 post-dose
Plasma pharmacokinetic parameters (SD) following single and repeated doses of 50, 100, and 200 mg of Etamicastat (BIA 5-453) in hypertensive subjects
AUC0-t: Area under the plasma concentration-time curve from time zero to last measurable plasma concentration (Plasma results on Day 1)
Time frame: D1 pre-dose, and H0.5 , 1, 2, 3, 4, 5, 6, 8, 10, 12, 16 post-dose
Plasma pharmacokinetic parameters (SD) following single and repeated doses of 50, 100, and 200 mg of Etamicastat (BIA 5-453) in hypertensive subjects
AUC0-24: AUC from time zero to 24h-post dose (Plasma results on Day 1)
Time frame: D1 pre-dose, and H0.5 , 1, 2, 3, 4, 5, 6, 8, 10, 12, 16 post-dose
Plasma pharmacokinetic parameters (SD) following single and repeated doses of 50, 100, and 200 mg of Etamicastat (BIA 5-453) in hypertensive subjects
Cmax: Maximum observed plasma concentration (Plasma results on Day 10)
Time frame: D10 pre-dose, and H0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12,16, 24, 48 and 72 h post-dose
Plasma pharmacokinetic parameters (SD) following single and repeated doses of 50, 100, and 200 mg of Etamicastat (BIA 5-453) in hypertensive subjects
tmax: time to reach maximum plasma concentration (Plasma results on Day 10)
Time frame: D10 pre-dose, and H0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12,16, 24, 48 and 72 h post-dose
Plasma pharmacokinetic parameters (SD) following single and repeated doses of 50, 100, and 200 mg of Etamicastat (BIA 5-453) in hypertensive subjects
AUC0-t: Area under the plasma concentration-time curve from time zero to last measurable plasma concentration (Plasma results on Day 10)
Time frame: D10 pre-dose, and H0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12,16, 24, 48 and 72 h post-dose
Plasma pharmacokinetic parameters (SD) following single and repeated doses of 50, 100, and 200 mg of Etamicastat (BIA 5-453) in hypertensive subjects
AUC0-24: AUC from time zero to 24h-post dose (Plasma results on Day 10)
Time frame: D10 pre-dose, and H0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12,16, 24, 48 and 72 h post-dose
Plasma pharmacokinetic parameters (SD) following single and repeated doses of 50, 100, and 200 mg of Etamicastat (BIA 5-453) in hypertensive subjects
C max : Maximum excretion rate (Urine results on Day 1)
Time frame: D1 pre-dose, and 0-4, 4-8, 8-12, 12-24 h post-dose
Urine pharmacokinetic parameters (SD) following single and repeated doses of 100 and 200 mg of Etamicastat (BIA 5-453) in hypertensive subjects
tmax : Time of Maximum Excretion Rate (Urine results on Day 1)
Time frame: D1 pre-dose, and 0-4, 4-8, 8-12, 12-24 h post-dose
Urine pharmacokinetic parameters (SD) following single and repeated doses of 100 and 200 mg of Etamicastat (BIA 5-453) in hypertensive subjects
AURC(0-tlast) : Area Under the Urine Excretion Curve from time zero to last time (Urine results on Day 1)
Time frame: D1 pre-dose, and 0-4, 4-8, 8-12, 12-24 h post-dose
Urine pharmacokinetic parameters (SD) following single and repeated doses of 100 and 200 mg of Etamicastat (BIA 5-453) in hypertensive subjects
AmtCUM : Cumulative Amount of Drug excreted in urine (Urine results on Day 1)
Time frame: D1 pre-dose, and 0-4, 4-8, 8-12, 12-24 h post-dose
Urine pharmacokinetic parameters (SD) following single and repeated doses of 100 and 200 mg of Etamicastat (BIA 5-453) in hypertensive subjects
C max : Maximum excretion rate (Urine results on Day 10)
Time frame: D10 pre-dose, and 0-4, 4-8, 8-12, 12-24, 24-48, 48 72 h post-dose
Urine pharmacokinetic parameters (SD) following single and repeated doses of 100 and 200 mg of Etamicastat (BIA 5-453) in hypertensive subjects
tmax : Time of Maximum Excretion Rate (Urine results on Day 10)
Time frame: D10 pre-dose, and 0-4, 4-8, 8-12, 12-24, 24-48, 48 72 h post-dose
Urine pharmacokinetic parameters (SD) following single and repeated doses of 100 and 200 mg of Etamicastat (BIA 5-453) in hypertensive subjects
AURC(0-tlast) : Area Under the Urine Excretion Curve from time zero to last time (Urine results on Day 10)
Time frame: D10 pre-dose, and 0-4, 4-8, 8-12, 12-24, 24-48, 48 72 h post-dose
Urine pharmacokinetic parameters (SD) following single and repeated doses of 100 and 200 mg of Etamicastat (BIA 5-453) in hypertensive subjects
AmtCUM : Cumulative Amount of Drug excreted in urine (Urine results on Day 10)
Time frame: D10 pre-dose, and 0-4, 4-8, 8-12, 12-24, 24-48, 48 72 h post-dose
Urine pharmacokinetic parameters (SD) following single and repeated doses of 100 and 200 mg of Etamicastat (BIA 5-453) in hypertensive subjects
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BIA 5-453 in people with Hypertension, run by Bial - Portela C S.A. at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax: Maximum observed plasma concentration (Plasma results on Day 1) (time frame: D1 pre-dose, and H0.5 , 1, 2, 3, 4, 5, 6, 8, 10, 12, 16 post-dose). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2017.